Proactive 715-420 Pulse TENS Electro-Stimulator Operating instructions

Brand: Proactive

Model: 715-420 Pulse TENS Electro-Stimulator

Type: Operating instructions

Manufactured in China

Physiotherapy • Physiothérapie

TENS Electro-Stimulator

Instructions

Please read this manual thoroughly

before using this device for the ﬁrst time.

Model: 715-420

A.M.G. Medical Inc.

8505 Dalton, Montréal, QC H4T 1V5

Canada • 1-800-363-2381

Distributed in the USA by:

AMG Medical, Inc. (USA)

8396 State Route 9, West Chazy, NY 12992

USA • 1-888-412-4992

Rev4 0122 P/N 861-715420

Generated by : Jean-François Perron

Special Instructions :

This is a double-sided,

saddle-stitched instruction booklet.

Flat Size : 24,811 cm x 18,81 cm

Assembled Size : Folded: 10,5 cm x 15 cm.

Open: 21 cm x 15 cm

Projet : 715-420 TENS Instructions EN Rev4 0122_original

Item No. : 715-420 Part No. : 861-715420

Colours :

B/W CMYK : Spots

TABLE OF CONTENTS

INTRODUCTION ..................................................................................3

What is pain? • How does TENS work?

SAFETY INFORMATION......................................................................4

Precautions •Contraindications • Adverse reactions • Warnings

DEVICE OVERVIEW.............................................................................6

Components and parts • Pulse duration • Pulse rate

Treatment mode • Time

INSTRUCTIONS FOR USE.................................................................9

Insert the battery • Connect electrodes to lead wires

Connect lead wires to the device • Place electrodes on skin

Select a treatment mode • Set the pulse rate

Set the pulse width • Set the timer

Set the intensity and begin treatment

After treatment is finished

CLEANING AND MAINTENANCE....................................................12

Cleaning the device • Electrodes

Cleaning the electrode cords • Maintenance

TROUBLESHOOTING ......................................................................13

ELECTRODE POSITIONING ............................................................14

CHECK / REPLACE THE BATTERY.................................................15

TECHNICAL SPECIFICATIONS .......................................................16

WARRANTY ....................................................................................17

3 4

INTRODUCTION

The Proactive™ Pulse™ Tens is intended to be used by adults for

the temporary relief of muscle and joint pain by applying electrical

nerve stimulation to the surface of the skin near the site

requiring therapy.

This device provides two independent, controllable output channels.

A pair of electrodes which can be connected to each output channel

and the current's parameters and intensity level can be adjusted

according to your needs.

1. What is pain?

Pain warns our body of injury to prevent additional damage. This

sensation is important because without it, vital parts of our bodies

might be injured without our knowledge. However, long-lasting,

persistent (chronic) pain, once diagnosed serves no apparent

purpose and reduces quality of life.

2. How does TENS work?

TENS (Transcutaneous Electrical Nerve Stimulation) refers to

the transmission of small electrical pulses through the skin to

the underlying peripheral nerves. The theory of TENS suggests two

different modes of operation:

In conventional (high frequency) TENS, continuous mild electrical

activity may block the pain signal traveling to the brain. If the pain

signal does not get through to the brain, the pain is not “felt”.

In low frequency TENS, short bursts of electrical activity may

stimulate the release of endorphins, the body's own pain-control

substance. Ask your physician or therapist for more details. No

matter what pain theory is used, TENS has been proven useful in pain

management for many patients in helping to make their lives better.

For external use only. The long-term effects of frequent electrical

stimulation are unknown. This device should be used only under

the continued supervision of a licensed medical practitioner.

Do not apply stimulation over the thyroid or carotid sinus regions,

as this could disrupt breathing, cardiac frequency or blood

pressure. Do not use while connected to high-frequency surgical

equipment or near shortwave or microwave therapy equipment.

Never use in environments with high humidity (ex.: bathroom).

Never place the electrodes anywhere on the front of the thorax or

transthoracically as it can increase the risk of ventricular fibrillation,

cause cardiac arrhythmia and lead to cardiac arrest. Never place

the electrodes in a way that would cause the current to go through

the head. Never use near the eyes, the genitals, the heart or on

areas which lack normal sensation. This stimulator should never

be used by patients who are noncompliant or are emotionally,

cognitively or mentally impaired. Keep the stimulator out of reach

of children.

WARNING

SAFETY INFORMATION

1. TENS is a symptomatic treatment that suppresses the sensation

of pain. It has no curative value and is not effective on pain that is

of central origin.

2. Do not use in the following situations: Undiagnosed pain

syndromes (until etiology is established). • Cancerous lesions that

are present in the treatment area. • Swollen, infected, inflamed

areas or skin eruptions (e.g. phlebitis, thrombophlebitis, varicose

veins, etc.). • Demand type implanted pacemaker or defibrillator,

or any metallic implant. • Epilepsy • Serious arterial circulatory

problems in the lower limbs • Abdominal or inguinal hernia

• Safety has not been established for use during pregnancy.

4. Precautions

• Do not adjust controls while operating machinery or vehicles.

• Turn the stimulator off before applying or removing electrodes.

• Only use with ProActive lead wires and electrodes.

• Long-term stimulation at the same electrode site may cause

skin irritation. Use only as prescribed by a physician.

• Never use in rooms where aerosols (sprays) are used

or pure oxygen is being administered. Do not use it near

highly flammable substances, gases or explosives.

• Apply the electrodes to clean, dry, and unbroken skin only.

• Keep electrodes separate during treatment. Electrodes coming

in contact with each other could result in improper stimulation

or skin burns.

• Should the treatment become unpleasant, discontinue the use

of this device until its use has been reassessed by a physician or

therapist.

5. Possible adverse reactions

Skin irritation or electrode burn under the electrodes.

Allergic skin reaction to electrode gel may also occur.

DEVICE OVERVIEW

Front

Side

Top

Belt clip

Slide cover

Intensity control

(on / off switch)

Lead wire

socket

Lead wire

socket

Pulse rate

Pulse width

Timer

Lead wire

socket

Cap

Mode

DEVICE OVERVIEW – DETAILS

Display LED

Lights up when a current

pulse is sent through the

corresponding channel.

At frequencies above 30

Hz, the LED appears to be

constantly lit.

On / off switch and intensity

controls:

When both controls are in the OFF

position, the device is turned off.

Turning the controls clockwise turns

on the corresponding channel

according to the chosen settings.

Turn clockwise to augment intensity

and counterclockwise to reduce the

intensity, or all the way to the OFF

position to stop the treatment.

Slide cover

Reveals the controls for

pulse width, pulse rate,

mode selector and

modulation, as well as

the battery. Your medical

professional may wish to

set these controls for you

and request that you leave

the cover in place.

Pulse duration (width)

A wider pulse will deliver stronger stimulation.

Using a combination of intensity and pulse

duration can stimulate different nerve groups.

Pulse duration is partially dependent on the

treatment mode and protocol.

Pulse rate

The pulse rate (hz or pulses / second) is

set depending on electrode placement.

For contiguous and dermatome electrode

placements (i.e. stimulating the pain site

directly), a quick pulse rate (over 80 Hz) is desired. You should not

perceive individual pulses but rather have the sensation of steady,

continuous stimulation.

Treatment modes

N - Normal (or conventional) TENS offers

complete control of the various parameters.

B - Burst mode provides a combination of

conventional and low-frequency TENS by

replacing the individual pulses by short “bursts” of 7 - 10 pulses.

In this mode, the treatment frequency cannot be adjusted.

M - Modulated mode attempts to prevent nerve accommodation by

continuously cycling the treatment intensity. In this mode, increase

the intensity only when at the cycle’s maximum intensity.

Time

Pain relief should begin shortly after the onset

of treatment. However, in some cases, it may

take as long as 30 minutes to achieve. TENS

units are typically operated for long periods of time,

with a minimum of 20 - 30 minutes and in some post-operation

protocols, as long as 36 hours. In general, pain relief will diminish

within 30 minutes of the cessation of stimulation.

INSTRUCTIONS FOR USE

1. Insert the battery

Slide the cover completely to uncover the battery cavity.

Insert a 9V battery (included), matching the positive

and negative ends of the battery to the markings, then close.

2. Connect electrodes to lead wires

Insert the lead wire connector into

the electrode connectors, ensuring

that no bare metal remains exposed.

3. Connect lead wires to the device

This device has 2 output channels,

which can be used simultaneously

(with 2 electrode pairs) or individually

(1 channel with 1 electrode pair).

After making sure that the device

is turned off, insert the wire plugs

into the sockets at the top of the unit.

Caution: Always use the lead

wires supplied with this unit.

4. Place electrodes on skin

Ensure that the skin surface

where the electrodes will be

placed is clean and dry.

Apply electrodes to the exact site

indicated by your physician.

The electrodes should be placed firmly

and evenly on the skin to ensure good contact.

Caution:

Always wash and dry the treatment area before applying the

electrodes. Do not turn the device on when the electrodes are not

applied to the treatment area. Never adjust, reposition, or remove

the electrodes while the device is still on. Always use this device

with 4cm x 4cm self-adhesive square electrodes, or larger. The

electrodes are for single-patient use only and should be discarded

when they no longer adhere properly.

5. Select a treatment mode

Expose the controls by sliding

front cover down from top of unit.

This switch has 3 positions: B for

burst stimulation, N for constant

stimulation, and M for

modulation stimulation. Push the

mode selector until engaged in

position desired.

6. Set the pulse rate

Turn the pulse rate dial to the

setting recommended by your

doctor or therapist. Unless

otherwise instructed, the pulse

rate control should be set in the

70 -120 Hz range.

7. Set the pulse width

Turn the pulse width dial to the

setting recommended by your

doctor or therapist. Unless

otherwise instructed, the pulse

width control should be set in the

70 -120 µs range.

8. Set the timer

Select the appropriate treatment

time (15 minutes, 30 minutes or

continuous) as recommended by

your doctor or therapist.

1211

9. Set the intensity and begin treatment

Slowly turn the intensity control dials clockwise. This will

turn the corresponding channels on and begin treatment.

To further increase the intensity, turn the dials clockwise.

To decrease the intensity or turn the device off, rotate the

dials counterclockwise to the desired setting or to the

"OFF" position.

10. After treatment is finished

Once the treatment time has elapsed, turn the intensity

control dials counterclockwise to the "OFF" position.

Unplug the lead wires from the device.

To remove the electrodes, lift one edge and gently peel

(do not pull on the lead wires because it may

damage the electrodes). Place the

electrodes on the liner and remove

the lead wire by twisting and

pulling at the same time.

CLEANING AND MAINTENANCE

1. Stimulator

Remove the battery before cleaning. Wipe the stimulator with a

soft, slightly moistened cloth. If a more thorough cleaning is

needed, you can also moisten the cloth with mild soapy water.

Do not submerge the stimulator or expose it to a large amount

of water. Do not use any chemical cleaners or abrasive agents

to clean this device. After use, store the stimulator in the storage

pouch to protect it from shock and dust. If you plan not to use it

for a prolonged period, remove the battery from the unit and store

in a cool, dry place.

2. Electrodes

• Use the device only with the leads and electrodes provided

with this device or sold under the ProActive brand, following

the placements and settings prescribed by your practitioner.

• It is recommended to use at minimum 4cm x 4cm self-adhesive,

square electrodes.

• Inspect your electrodes before every use and replace as needed.

Reusing electrodes too many times may cause slight skin irritation,

low adhesion, or ineffective stimulation.

• Between uses, store the electrodes in the resealed bag in a cool

dry place. It may be helpful, between applications, to moisten

their adhesive surface with a few drops of water (be careful not to

over-saturate) and then let them air-dry to help them last longer.

Reusable, self-adhesive electrodes

1413

TROUBLESHOOTING

Should any malfunction occur while using this device:

• Verify that the controls are set to the appropriate therapy settings

and adjust accordingly.

• Verify that the lead wires are correctly connected to the device.

They should be inserted completely into the sockets.

• Verify whether the LEDs light up when the unit is in use. If

necessary, insert a new battery.

• Inspect the lead wires for damage and replace if necessary.

• Verify that the electrodes are properly applied to the skin in a

position that promotes proper functioning of the device. See the

notes on electrode positioning on the next page for more details.

• If the above fails, do not attempt any repairs to the device or

any of its accessories. Contact us at 1-800-363-2381 for repair

information.

4. Maintenance

• Do not attempt any repairs to the device or any of its accessories.

• The manufacturer will not be held responsible for the results

of maintenance or repairs by unauthorized persons.

• Check the device before each use for signs of wear and/or

damage. Replace worn items (electrodes, lead wires) as required.

3. Cleaning the electrode cords

Clean the electrode cords by wiping them with a damp cloth.

Coating them lightly with talcum powder will reduce tangles

and help them last longer.

ELECTRODE POSITIONING

Electrode positioning can be one of the most important parameters

in achieving success with TENS therapy. Of utmost importance is

the willingness of the clinician to try the various styles of electrode

placement to find which method best fits the needs of each

individual patient.

Everyone responds to electrical stimulation differently and,

accordingly, their needs may vary from the conventional settings

suggested here. If the inital results are not positive, feel free to

experiment. Once an effective positioning has been achieved,

mark down the electrode sites and the settings at the end of this

manual so that it can easily be replicated at home.

Contiguous placement is the most common technique. It involves

placing the electrodes alongside the site of localized pain, in such a

way as to direct the flow of current through or around the pain site.

In a single channel application, this would involve placing the

electrodes on either side of the pain site in the case of limb or deep

tissue pain. Electrode placement on the posterior and anterior

aspects of the affected limb will allow the current to flow completely

through the limb, and thus through the endogenous pain site. With

a two channels application, the clinician may either direct the

current flow to cross through the pain site or, in what is called the

“bracket” method allows the current flow on either side of the

painful area, generally through the nerve branches that feed into

the pain site.

1615

Over time, in order to ensure the functional safety

of this device, changing the battery is necessary.

1. Make sure that both intensity controls

are switched to the off position.

2. Slide the battery compartment cover

and remove.

3. Remove the battery from the compartment.

4. Insert the battery into the compartment.

Note the polarity indicated on the battery

and in the compartment.

5. Replace the battery compartment cover

and slide to close.

CH2

TECHNICAL SPECIFICATIONS

Mechanism Technical description

Channel Dual, isolated between channels

Pulse amplitude Adjustable, 0 - 80 mA

at 500 ohm load each channel

Pulse rate Adjustable, from 2 to 150 Hz

Pulse width Adjustable, from 30 to 260 microseconds

Modulation mode Pulse rate is automatically varied in a

cyclic pattern over an interval of nominally

10 seconds (in max 150 Hz). Pulse rate

decreases linearly over a period of

4 seconds from the control setting value

to a value which is 40% less. The lower

pulse rate will continue for 1 second. Then

increase linearly over a 4 seconds period

to its original value. The original pulse rate

will continue for 1 second. The cycle is

then repeated.

Burst mode Bursts occur twice every second.

Pulse width (adjustable), frequency:

100 Hz

Wave form Asymmetrical bi-phasic square pulse

Timer 15, 30 minutes or continuous

Voltage 0 to 40 V (load: 500 ohm)

Max charge per pulse 20 micro-coulombs

Power supply One 9 V battery (alkaline or

nickel-cadminum rechargeable)

Battery life Approximately 50 hours at nominal settings

Size 95 mm (H) x 65 mm (W) x 23.5 mm (T)

Weight 115 grams (battery included)

CHECK / REPLACE THE BATTERY

Operating Conditions 5°C ~ 40°C; 30% RH ~ 75% RH

Storage Conditions -10°C ~ 55°C; 10% RH ~ 90% RH

LIMITED WARRANTY

A.M.G. Medical Inc. warrants the stimulator to be free from defects in

material and workmanship for a period of one (1) year, to be proven by

means of the sales receipt or invoice. This warranty is valid for the

original purchaser only. Any alterations, abuse, misuse or accidental

damage voids this warranty. Repairs under warranty do not extend the

warranty period. For service under warranty, call us at:

1-800-363-2381, between 8:30 AM and 5:00 PM EST.

• The following is excluded under the warranty:

A) All damage which has arisen due to improper treatment,

e.g. nonobservance of the user instructions.

B) All damage which is due to repairs or tampering by the customer

or unauthorized third parties.

C) Damage which has arisen during transport from the

manufacturer to the consumer or during transport to

the service centre.

D) Accessories which are subject to normal wear and tear.

• Liability for direct or indirect consequential losses caused by the

unit are excluded even if the damage to the unit is accepted as a

warranty claim.

Proactive 715-420 Pulse TENS Electro-Stimulator Operating instructions

Brand: Proactive

Model: 715-420 Pulse TENS Electro-Stimulator

Type: Operating instructions

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Proactive 715-420 Pulse TENS Electro-Stimulator Operating instructions

Proactive 715-420 Pulse TENS Electro-Stimulator Operating instructions

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